FDAsafety guidance95% confidence
FDA TA — ANDA218552
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to APOTEX; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Application ANDA218552. Sponsor: APOTEX. Submission status: TA. Submission type: ORIG. Review priority: STANDARD.
Supporting Context
- Therapeutic area
- Not specified
- Sub-indication
- General
Related signal: FDA Submission Update for ANDA218552 by APOTEX